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Phase 1Status unknown

A Study of TY-302 in Patients With Advanced Solid Tumors

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of TY-302 Capsules in Patients With Advanced Solid Tumors in China

Sponsor
TYK Medicines, Inc (Industry)
Enrolment
60 planned
Conditions
Breast Cancer; Solid Tumor
Interventions
TY-302: capsule, 25mg/50mg ; Tamoxifen: tablet,10mg
Ages
adults, older adults
Registry
NCT04433494

Full record on ClinicalTrials.gov

From the registry

The primary objective of this study is to evaluate the safety and tolerability of TY-302 single and the combination with Tamoxifen in dose-escalation and dose-expansion study.The drugs involved in this study are: * TY-302 * Tamoxifen

Primary outcomes

  • Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TY-302
  • Dose Limiting Toxicity (DLT) of TY-302
  • Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TY-302 combine with Tamoxifen
  • Dose Limiting Toxicity (DLT) of TY-302 combine with Tamoxifen

History

  1. Study completion

  2. Primary completion

  3. Last registry update

  4. Started

  5. Registered